Antidote AndexXa to have a Restricted Release: Bill Lis, Portola CEO

  • Eliquis (Apixaban) Medical Record Review & Outsourcing Services

AndexXa, the only antidote for Factor Xa blood thinner, approved by the U.S. Food and Drug Administration(FDA) on May 4 to reverse uncontrollable bleeding problems, will be initially available in only those 40 to 50 hospitals where the clinical trials were held. It will later be provided to about 1,000 different providers after Portola manages to get an FDA nod for the new manufacturing process.

Despite the urgent requirement for a reversal agent for Xarelto and Eliquis, CEO of Portola Pharmaceuticals Bill Lis announced that AndexXa will have a limited release until next year.

AndexXa was approved by the FDA as an antidote for Xarelto and Eliquis after two years, with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, sudden death, and other serious and life-threatening adverse events.

Nearly 20,000 Xarelto lawsuits are pending before Judge Eldon Fallon in the U.S. District Court as part of a federal multidistrict litigation (MDL) in the Eastern District of Louisiana.

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